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Poster Display session 3

3186 - The landscape of immuno-oncology clinical trials in China

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Immunotherapy

Tumour Site

Presenters

Dawei Wu

Citation

Annals of Oncology (2019) 30 (suppl_5): v475-v532. 10.1093/annonc/mdz253

Authors

D. Wu, H. Huang, N. Li, S. Wang, H. Fang, Y. Yu, Y. Bai, B. Xu, Y. Sun

Author affiliations

  • Department Of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN

Resources

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Abstract 3186

Background

A bran-new landscape of immuno-oncology (IO) is arising in China rapidly, with IO development a hotspot in biopharmaceutical industries. Moreover, a paucity of data on the panorama of IO clinical trials in China inspired us to present the systemic analysis for stakeholders in this field.

Methods

Based on the Platform for Registry and Publicity of Drug Clinical Trials, a national authoritative database by China Food and Drug Administration, the trials for IO agents issued from 2013 to 2018 were explored using newly developed agents (by six types of mechanism and targets) and the number of initiated trials as key indicators. The clinical development stages of all agents were presented by targets. In addition, time trends in annually initiated trials and cumulative indication distribution were investigated.

Results

There were 62 IO agents and 230 initiated trials in China from 2013 to 2018, with 46 (74.2%) agents and 154 (67.0%) trials from domestic firms. The 62 agents modulated 18 targets focusing on PD-1 (17, 27.4%), PD-L1 (12, 19.4%) and unspecified tumor-associated antigens (5, 8.1%). Only 8 agents of cell therapy were ever developed for registration purpose. PD-1/L1 targets were most extensively investigated with a total of 180 (78.3%) trials and 4 agents approved. The annual number of trials showed an upward trend, and the sharp increase for trials of T-cell targeted immuno-modulators was seen with an average growth rate of 199.1% since 2016. In terms of cancer types, solid tumor (56, 24.3%), non-small cell lung cancer (45, 19.6%) and hepatocellular cancer (20, 8.7%) were the most common. Only 14 (6.1%) trials applied a biomarker enrichment strategy.Table:

1293P The landscape of immuno-oncology targets in clinical development in China since 2013

TypesTargetsAgents N = 62 (%)Trials N = 230 (%)
TotalPhase IPhase II/IIIApprov ed
T-cell targeted immuno- modulatorPD-117 (27.4)674129 (56.1)
PD-L112 (19.4)5751 (22.2)
CTLA-43 (4.8)1211 (4.8)
IDO1/TDO222
IDO1111
CD137111
LAG3111
OX40111
PD-1/CTLA-4111
PD-L1/CTLA-4111
PD-L1/ TGF-βRII111
Other immuno- modulatorUnspecified115 (2.2)
CD47111
MUC1111
Cancer vaccineTLR222
EGF111
MUC1111
Cell TherapyUnspecified4 (6.5)224 (1.7)
CD193 (4.8)33 (1.3)
BCMA111
Oncolytic virusGM-CSFR4 (6.5)139 (3.9)
CD3-targeted bispecific mAbCD19111
HER2111

Conclusions

Though a gap exists in the number of agents and targets between China and the global pipeline, the rising capability of IO has been achieved in China recently. Efforts should be further made in novel targets, cell therapy for registration purpose, Chinese unique cancers and new trial designs.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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